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| Name | Class |
|---|---|
| Zensei Pharmaceutical Co., Ltd. | UNKNOWN |
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This study will be an open-label, randomized 2-way cross-over study to evaluate bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese male subjects. Approximately 48 subjects will participate in this study to receive a single dose treatments of levocetirizine ODT 5 milligram (mg) or levocetirizine IRT 5 mg. In Part 1, subjects will randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single dose of levocetirizine ODT 5 mg with water or single dose levocetirizine IRT 5 mg with water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT when taken with water in the fasted state will be assessed. In Part 2, subjects will be randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single dose levocetirizine ODT 5 mg without water or single dose levocetirizine IRT 5 mg with water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be assessed. There will be at least a 5-day wash out period between the intervention periods. The duration of each subject's participation in each part will be approximately 7 weeks from screening to follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects of Group A: Part 1 | Experimental | Subjects in Group A will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 2. |
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| Subjects of Group B: Part 1 | Experimental | Subjects in Group B will be randomized to receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2. |
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| Subjects of Group C: Part 2 | Experimental | Subjects in Group C will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg without water in fasted state in Period 2. |
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| Subjects of Group D: Part 2 | Experimental | Subjects in Group D will be randomized to receive levocetirizine ODT 5 mg without water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocetirizine IRT 5 mg | Drug | Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine | Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
| Part 2: AUC(0-t) of Levocetirizine | Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
| Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine | Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
| Part 2: Cmax of Levocetirizine | Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine | Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Japanese male subjects will be part of this study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 812-0025 | Japan |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 133 participants were screened, of them, 72 participants were randomized to receive study treatment. All participants except one participant randomized in Part 2 (Initial study) completed the study.
This was a single center, single dose, open-label, randomized, 2-part, 2-way crossover study. Bioequivalence (BE) between levocetirizine (levo) oral disintegrating tablet (ODT) and levocetirizine immediate release tablet (IRT) was evaluated in 72 healthy Japanese participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water) | All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| FG001 | Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg | All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| FG002 | Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water) | All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| FG003 | Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg | All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1:Treatment Period 1 (3 Days) |
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| Part 1:Washout Period (at Least 5 Days) |
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| Part 1:Treatment Period 2 (10 Days) |
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| Part 2:Treatment Period 1 (3 Days) |
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| Part 2:Washout Period (at Least 5 Days) |
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| Part 2:Treatment Period 2 (10 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water) | All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine | Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). | Pharmacokinetic (PK) Population is defined as all participants who were administered at least one dose of study treatment and blood samples for plasma drug concentration were taken and analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Hours*nanogram per milliliter (Hr*ng/mL) | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
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On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 18 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Levocetirizine ODT 5 mg | All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2018 | Jul 29, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 1, 2018 | Jul 31, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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This study is 2-way crossover 2 part study. In Part 1, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT taken with water in the fasted state will be done and In Part 2, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be done.
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| Levocetirizine ODT 5 mg | Drug | Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water. |
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| Part 2: AUC(0-inf) of Levocetirizine | Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine | Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: Tmax of Levocetirizine | Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine | Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: t1/2 of Levocetirizine | Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine | Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: %AUCex of Levocetirizine | Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine | Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: CL/F of Levocetirizine | Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine | Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: Vz/F of Levocetirizine | Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine | Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: Kel (lambda_z) of Levocetirizine | Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Mean Residence Time (MRT) of Levocetirizine | Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 2: MRT of Levocetirizine | Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
| Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Up to 18 days |
| Part 2: Number of Participants With AEs and SAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Up to 18 days |
| Part 1: Change From Baseline in Albumin and Total Protein Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Albumin and Total Protein Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Amylase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Amylase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change Form Baseline in Hematocrit | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change Form Baseline in Hematocrit | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Mean Corpuscle Hemoglobin | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Mean Corpuscle Hemoglobin | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Mean Corpuscle Volume | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Mean Corpuscle Volume | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Red Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Red Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Change From Baseline in Reticulocytes | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 2: Change From Baseline in Reticulocytes | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
| Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. | Pre-dose (Day 1) and 48 hours post-dose |
| Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. | Pre-dose (Day 1) and 48 hours post-dose |
| Part 1: Urine Potential of Hydrogen (pH) | Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Pre-dose (Day 1) and 48 hours post-dose |
| Part 2: Urine Potential of Hydrogen (pH) | Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Pre-dose (Day 1) and 48 hours post-dose |
| Part 1: Urine Specific Gravity | Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. | Pre-dose (Day 1) and 48 hours post-dose |
| Part 2: Urine Specific Gravity | Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. | Pre-dose (Day 1) and 48 hours post-dose |
| Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
| Part 2: Change From Baseline in SBP and DBP | Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
| Part 1: Change From Baseline in Heart Rate | Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
| Part 2: Change From Baseline in Heart Rate | Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
| Part 1: Change From Baseline in Body Temperature | Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
| Part 2: Change From Baseline in Body Temperature | Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
| Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
| Part 2: Change From Baseline in Heart Rate (ECG) | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
| Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
| Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
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| BG001 | Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg | All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| BG002 | Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water) | All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| BG003 | Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg | All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. |
| BG004 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Part 1: Levocetirizine IRT 5 mg | All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule. |
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| Primary | Part 2: AUC(0-t) of Levocetirizine | Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
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| Primary | Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine | Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Nanogram per milliliter (ng/mL) | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
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| Primary | Part 2: Cmax of Levocetirizine | Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose |
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| Secondary | Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine | Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: AUC(0-inf) of Levocetirizine | Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine | Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. | PK Population | Posted | Median | Full Range | Hours | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: Tmax of Levocetirizine | Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine | Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Hours | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: t1/2 of Levocetirizine | Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Hours | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine | Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Percentage AUCex | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: %AUCex of Levocetirizine | Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Percentage AUCex | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine | Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Liters per hour | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: CL/F of Levocetirizine | Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Liters per hour | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine | Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Liters | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: Vz/F of Levocetirizine | Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Liters | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine | Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Per hour | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: Kel (lambda_z) of Levocetirizine | Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Per hour | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Mean Residence Time (MRT) of Levocetirizine | Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population | Posted | Geometric Mean | 95% Confidence Interval | Hours | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 2: MRT of Levocetirizine | Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Hours | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose |
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| Secondary | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety Population consists of all participants who were administered at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 days |
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| Secondary | Part 2: Number of Participants With AEs and SAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Count of Participants | Participants | Up to 18 days |
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| Secondary | Part 1: Change From Baseline in Albumin and Total Protein Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Albumin and Total Protein Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | g/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Amylase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Amylase Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter (UMOL/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | UMOL/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter (MMOL/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | MMOL/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Percentage | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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|
| Secondary | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Percentage | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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|
| Secondary | Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Giga per liter (GI/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | GI/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | G/L | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change Form Baseline in Hematocrit | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change Form Baseline in Hematocrit | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Mean Corpuscle Hemoglobin | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Mean Corpuscle Hemoglobin | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Mean Corpuscle Volume | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Mean Corpuscle Volume | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Red Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Red Blood Cell Count | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Reticulocytes | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Percentage of reticulocytes | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Reticulocytes | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Percentage of reticulocytes | Baseline (Day 1, Pre-dose) and 48 hours post-dose |
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| Secondary | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. | Safety Population. | Posted | Count of Participants | Participants | Pre-dose (Day 1) and 48 hours post-dose |
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| Secondary | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Count of Participants | Participants | Pre-dose (Day 1) and 48 hours post-dose |
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| Secondary | Part 1: Urine Potential of Hydrogen (pH) | Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety Population. | Posted | Mean | Standard Deviation | pH | Pre-dose (Day 1) and 48 hours post-dose |
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| Secondary | Part 2: Urine Potential of Hydrogen (pH) | Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | pH | Pre-dose (Day 1) and 48 hours post-dose |
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| Secondary | Part 1: Urine Specific Gravity | Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Pre-dose (Day 1) and 48 hours post-dose |
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| Secondary | Part 2: Urine Specific Gravity | Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Pre-dose (Day 1) and 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in SBP and DBP | Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Heart Rate | Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Heart Rate | Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Body Temperature | Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Body Temperature | Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in Heart Rate (ECG) | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
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| Secondary | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. | Posted | Mean | Standard Deviation | Millisecond | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
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| Secondary | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Millisecond | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose |
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Part 1: Levocetirizine IRT 5 mg | All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Part 2: Levocetirizine ODT 5 mg | All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state either in Period 1 or Period 2 as per randomization schedule. | 0 | 48 | 0 | 48 | 6 | 48 |
| EG003 | Part 2: Levocetirizine IRT 5 mg | All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state either in Period 1 or Period 2 as per randomization schedule. | 0 | 48 | 0 | 48 | 0 | 48 |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D010038 |
| Otorhinolaryngologic Diseases |
| Aspartate amino transferase |
|
| Creatine kinase |
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| Gamma glutamyl transferase |
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| Lactate dehydrogenase |
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| Aspartate amino transferase |
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| Creatine kinase |
|
| Gamma glutamyl transferase |
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| Lactate dehydrogenase |
|
| Creatinine |
|
| Uric acid |
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| Creatinine |
|
| Uric acid |
|
| Chloride |
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| Glucose |
|
| High density lipids cholesterol |
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| Potassium |
|
| Low density lipids cholesterol |
|
| Sodium |
|
| Phosphorus inorganic |
|
| Triglycerides |
|
| Urea/BUN |
|
| Chloride |
|
| Glucose |
|
| High density lipids cholesterol |
|
| Potassium |
|
| Low density lipids cholesterol |
|
| Sodium |
|
| Phosphorus inorganic |
|
| Triglycerides |
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| Urea/BUN |
|
| Lymphocytes |
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| Monocytes |
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| Total neutrophils levels |
|
| Lymphocytes |
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| Monocytes |
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| Total neutrophils levels |
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| Occult blood, Pre-dose, negative |
|
| Occult blood, Pre-dose, trace |
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| Occult blood, 48 hours, negative |
|
| Occult blood, 48 hours, trace |
|
| Glucose, Pre-dose, negative |
|
| Glucose, 48 hours, negative |
|
| Ketones, Pre-dose, negative |
|
| Ketones, Pre-dose, positive (1+) |
|
| Ketones, 48 hours, negative |
|
| Protein, Pre-dose, negative |
|
| Protein, 48 hours, negative |
|
| Urobilinogen, Pre-dose, trace |
|
| Urobilinogen, 48 hours, trace |
|
| Occult blood, Pre-dose, negative |
|
| Occult blood, 48 hours, negative |
|
| Occult blood, 48 hours, trace |
|
| Glucose, Pre-dose, negative |
|
| Glucose, 48 hours, negative |
|
| Ketones, Pre-dose, negative |
|
| Ketones, Pre-dose, positive (1+) |
|
| Ketones, 48 hours, negative |
|
| Protein, Pre-dose, negative |
|
| Protein, 48 hours, negative |
|
| Urobilinogen, Pre-dose, trace |
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| Urobilinogen, 48 hours, trace |
|
| SBP, 48 hour |
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| DBP, 1 hour |
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| DBP, 24 hour |
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| DBP, 48 hour |
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| SBP, 48 hour |
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| DBP, 1 hour |
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| DBP, 24 hour |
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| DBP, 48 hour |
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| 48 hour |
|
| 48 hour |
|
| 48 hour |
|
| 48 hour |
|
| QRS duration, 1 hour |
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| QRS duration, 48 hour |
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| QT interval, 1 hour |
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| QT interval, 48 hour |
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| QTcF interval, 1 hour |
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| QTcF interval, 48 hour |
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| QRS duration, 1 hour |
|
| QRS duration, 48 hour |
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| QT interval, 1 hour |
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| QT interval, 48 hour |
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| QTcF interval, 1 hour |
|
| QTcF interval, 48 hour |
|